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CONSTELLA is a brand name for Linaclotide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 09/2024
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
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and 14 CLINICAL TRIALS. 2 Geriatrics Irritable Bowel Syndrome with Constipation: Of 1,605 IBS-C patients in the placebo-controlled clinical studies of CONSTELLA, 85 (5%) were at least 65 years of age, while 20 (1%) were at least 75 years old.
Clinical studies of CONSTELLA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
Chronic Idiopathic Constipation:
Of 2,498 CIC patients in the placebo-controlled clinical studies of CONSTELLA, 273 (11%) were at least 65 years of age, while 56 (2%) were at least 75 years old. Clinical studies of CONSTELLA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
2 CONTRAINDICATIONS CONSTELLA is contraindicated in: • pediatric patients under 6 years of age due to the risk of serious dehydration. 3 Pediatrics. • patients who are hypersensitive to linaclotide or to any ingredient in the formulation or component of the container.
For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • patients with known or suspected mechanical gastrointestinal obstruction. CONSTELLA (linaclotide) Page 6 of 43 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions CONSTELLA is contraindicated in children less than 6 years of age.
In nonclinical studies in neonatal mice, administration of a single, clinically relevant oral dose of linaclotide caused deaths due to dehydration. 3 Pediatrics, 16 NON-CLINICAL TOXICOLOGY. 1 Dosing Considerations Patients should be counselled that improvement of bowel symptoms should occur within the first week of CONSTELLA treatment, but improvement of abdominal symptoms may take longer (see 14 CLINICAL TRIALS).
3 Pediatrics 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 9 8 ADVERSE REACTIONS ................................................................................................
14 9 DRUG INTERACTIONS ................................................................................................ 15 10 CLINICAL PHARMACOLOGY .......................................................................................
17 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 19 PART II: SCIENTIFIC INFORMATION .......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Physicians should periodically assess the need for continued treatment with CONSTELLA. Patients on treatment who experience severe diarrhea should stop CONSTELLA and contact their physician (see 7 WARNINGS AND PRECAUTIONS). Exceeding the daily dose of 145 mcg for the treatment of CIC is not expected to increase efficacy.
2 Recommended Dose and Dosage Adjustment Irritable Bowel Syndrome with Constipation (IBS-C) in adults The recommended dose of CONSTELLA is 290 mcg taken orally once daily on an empty stomach, at least 30 minutes before a meal. 3 Pharmacokinetics.
Chronic Idiopathic Constipation (CIC) in adults The recommended dose of CONSTELLA is 145 mcg taken orally once daily on an empty stomach, at least 30 minutes before a meal. 3 Pharmacokinetics. A dose of 72 mcg may be used depending on individual clinical presentation or response to the starting dose.
Functional Constipation (FC) in pediatric patients 6 to 17 years of age The recommended dose of CONSTELLA in pediatric patients 6 to 17 years is 72 mcg taken orally once daily on an empty stomach, at least 30 minutes before a meal.
3 Pharmacokinetics. Special Populations No dose adjustments are required for patients with hepatic or renal impairment. 3 Pharmacokinetics. 4 Administration CONSTELLA capsules should be taken orally once daily on an empty stomach, at least 30 minutes before a meal.
The capsules should be swallowed whole and should not be chewed. For patients who are unable to swallow the capsule whole, CONSTELLA capsules can be opened and administered orally in applesauce or with water or administered with water via a nasogastric or gastric tube.
Sprinkling of CONSTELLA beads on other soft foods or in other liquids has not been tested. CONSTELLA (linaclotide) Page 7 of 43 For administration in applesauce: • Place one teaspoonful of applesauce at room temperature into a clean container.
• Open the capsule. • Sprinkle entire contents (beads) on applesauce. • Consume the contents immediately. Do not chew the beads. Do not store the applesauce and beads for later use. For administration in water: • Pour approximately 30 mL of bottled water at room temperature into a clean cup.
• Open the capsule. • Sprinkle entire contents (beads) into the water. • Gently swirl beads and water for at least 20 seconds. • Swallow the mixture of beads and water immediately. • Add another 30 mL of water to any beads remaining in the cup, swirl for 20 seconds and swallow immediately.
• Do not store the bead-water mixture for future use.
Note:
The drug is coated on the surface of the beads and will dissolve off the beads into the water. The beads will remain visible and will not dissolve. Therefore, it is not necessary to consume all of the beads to deliver the complete dose.
For nasogastric or gastric feeding tube administration in water: • Open the capsule and empty the beads into a clean container with 30 mL of room temperature bottled water. • Mix by gently swirling beads for at least 20 seconds. • Draw up the bead-water mixture into an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 seconds) to dispense the syringe contents into the tube.
• Add another 30 mL of water to any beads remaining in the container and repeat the process. • After administering the bead-water mixture, flush the nasogastric/gastric tube with a minimum of 10 mL of water. • Use the mixture of beads and water immediately.
Do not store for future use.
Note:
It is not necessary to flush all of the beads through to deliver the complete dose. A meal can be consumed 30 minutes after dosing of CONSTELLA. 5 Missed Dose In the event that a dose is missed, the patient should skip that dose. Do not take two capsules to account for the missed dose.
Wait until it is time for the next dose and then take the usual dose on an empty stomach. CONSTELLA (linaclotide) Page 8 of 43 5 OVERDOSAGE There is limited experience with overdose of CONSTELLA. During the clinical development program of CONSTELLA, single doses of 2897 mcg were administered to 22 healthy volunteers; the safety profile in […]
20 13 PHARMACEUTICAL INFORMATION ............................................................................ 20 14 CLINICAL TRIALS ........................................................................................................
35 15 MICROBIOLOGY ........................................................................................................ 36 16 […]